This prospective study assessed fluvoxamine serum concentrations under
two different fixed doses. The study included 15 male and female pati
ents who met the DSM-III-R criteria for major depression. They were pr
escribed 50 mg fluvoxamine twice a day for 2 weeks and 100 mg twice a
day thereafter. Drug monitoring was carried out on days 14 and 28. Flu
voxamine serum concentrations were highly variable between patients. A
fter the dose was doubled, the serum concentrations of fluvoxamine inc
reased disproportionately (mean, 3.4-fold), and there was a significan
tly (p < 0.05) more pronounced increase in men (4.6-fold) than in wome
n (2.4-fold). These results provide evidence of nonlinear, sex-depende
nt pharmacokinetics of fluvoxamine.